Proximal Tool

GUDID 00878953003023

Proximal Cylinder Insertion Tool

AMERICAN MEDICAL SYSTEMS, INC.

Penile prosthesis implantation instrument
Primary Device ID00878953003023
NIH Device Record Keyf89095f0-d9c6-4ec9-8f04-5853193025be
Commercial Distribution StatusIn Commercial Distribution
Brand NameProximal Tool
Version Model Number72404120
Company DUNS125111448
Company NameAMERICAN MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100878953003023 [Primary]

FDA Product Code

JCWProsthesis, Penis, Inflatable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-13
Device Publish Date2014-09-24

Devices Manufactured by AMERICAN MEDICAL SYSTEMS, INC.

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00878953004051 - Rear Tip Extender2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004068 - Rear Tip Extender2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004075 - Rear Tip Extender2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004082 - Rear Tip Extender2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004099 - Rear Tip Extender2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004105 - Rear Tip Extender2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis

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